A Carilion Clinic psychiatrist is enrolling children in a national clinical trial to help determine if a compound aimed at restoring gut health can alleviate symptoms of autism.
To participate, children need to be between 3 and 8 and have an autism spectrum disorder.
Dr. Anita Kablinger said parents who suspect their children have autism but do not have a diagnosis are also welcome since she evaluates the children during the initial visit.The trial is on a bio-med called CM-AT that was developed by New York-based Curemark.
“The person who founded this company noticed that when she treated autistic kids they tended to be very restrictive in their diets, more so than most kids,” Kablinger said. They eat very high carb foods food — noodles, potatoes, cereal — and shun protein.
Curemark looked for a commonality and found that many kids with autism, though not all, lack chymotrypsin, an enzyme that breaks down proteins in the small intestine. Just as proteins are essential in building healthy bodies so, too, are they essential in building healthy brains.
“It could be kids with autism who eat this self-restricted diet don’t eat protein because they are incapable of breaking it down,” she said.
The study focuses on 3- to 8-year-olds because that’s a busy time for building connections within the brain.
“Nobody knows No. 1 if this compound is effective. And nobody knows if you catch it early, are you changing the course of the illness,” she said.
The Food and Drug Administration has put CM-AT on the fast track, which means once these Phase 3 trials are concluded, if it proves effective, approval will come quickly.
“There is no medication approved for the core symptoms of autism,” Kablinger said. “There are no other compounds in the pipeline from any pharmaceutical or biotech that are looking for the treatment for addressing core symptoms.”
The compound has made it through the first two phases that assess its safety. So far, it’s been well tolerated without side effects, she said.
The trial is double blind and requires a 14-week commitment from families. The initial consultation lasts for several hours as Kablinger assesses the child to determine if he falls on the spectrum.
If accepted into the study, parents would need to sprinkle a compound three times a day on their child’s food. Half of the participants will receive CM-AT and half a placebo.
Though kids won’t have to endure any needle sticks for blood draws, parents will have to collect stool samples five times.
They’ll also have to visit with Kablinger every two weeks and provide information on their child’s behavior.
The Carilion site is one of 20 across the country participating in the study. Kablinger has enrolled four families and has two more to screen this week. She’s hoping to have between 10 and 15 kids.
She said families are coming from the New River Valley, North Carolina and Northern Virginia to participate. She’s flexible in scheduling appointments and will meet with families on nights and weekends.
The Centers for Disease Control estimates one in 68 kids falls on the autism spectrum that ranges from high functioning to nonverbal and unable to care for themselves.
For more information on participating, call 540-981-8829.